The Effect of Cagrilintide and Semaglutide Combination Treatment Compared to a Weight-loss Inducing Diet on Energy Metabolism in Persons Living With Obesity: an Open-label Randomised Study
Novo Nordisk A/S
Summary
In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Male or female (sex assigned at birth). * Age 18-65 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2) at screening (Visit 1). Excess body weight should be due to excess adipose tissue, as judged by the investigator. Exclusion criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * History of diabetes mellitus of any type, other than gestational dia…
Interventions
- DrugCagriSema (Cagrilintide B + semaglutide I)
Cagrilintide and semaglutide will be administered subcutaneously.
- BehavioralLow Energy Diet
Participants will receive dietary intervention as per diet intervention manual.
Locations (2)
- Advent Health-Res InstOrlando, Florida
- Pennington Biomed Res CtrBaton Rouge, Louisiana